Axial Spondylarthritis (axSpA)UPSTANDNCT04846244
A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib
An observational study of Axial Spondylarthritis (axSpA), run by AbbVie at 160 sites in 16 countries.
Trial summary
Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondylarthritis (axSpA)
- How many people
- 708 participants
- Where
- 160 sitesin 16 countries
- Study dates
- 30 Apr 2021to 24 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with Radiographic Axial Spondylarthritis (r-axSpA) who have been prescribed upadacitinib in the course of routine practice according to relevant approved licenses.
Who may be able to join
- Clinical diagnosis of Axial Spondylarthritis (axSpA) according to the ASAS criteria.
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 at Baseline.
- Total back pain score >= 4 at Baseline.
- Inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to contraindication for NSAIDs as defined by the investigator.
- Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.
Who cannot join
- Prior exposure to any Janus kinase (JAK) inhibitor.
- Participants demonstrating active symptoms of fibromyalgia as per clinical diagnosis.
- Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
- Unwillingness or inability to comply with the study requirements, including completion of patient reported outcome questionnaires.
- Participants who cannot be treated with upadacitinib according to the applicable approved label (e.g., contraindications).
- Vulnerable or protected adult patients with lack of capability to give informed consent.
Trial locations and contacts
160 sites in 16 countries.
160 sites in 16 countries
France32 sites
CH du Pays d'AIX /ID# 229095
Aix-en-Provence, 13616
CHU Amiens-Picardie Site Sud /ID# 228821
Amiens, Somme, 80054
Centre Hospitalier d'Arras /ID# 228833
Arras, 62022
CHU de Besancon - Jean Minjoz /ID# 230528
Besançon, Doubs, 25030
CHU de Besancon - Jean Minjoz /ID# 242499
Besançon, Doubs, 25030
CHU Bordeaux - Hopital Pellegrin /ID# 230548
Bordeaux, Gironde, 33076
Infirmerie Protestante /ID# 228794
Caluire-et-Cuire, Rhone, 69300
CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 229092
Clermont-Ferrand, 63000
C. H. Sud Francilien /ID# 228826
Corbeil-Essonnes, 91106
CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 230947
La Roche-sur-Yon, 85000
CHU Grenoble - Hopital Michallon /ID# 228792
La Tronche, 38700
CHU Lille - Hôpital Roger Salengro /ID# 228820
Lille, 59037
CHU Limoges - Dupuytren 1 /ID# 229094
Limoges, Franche-Comte, 87042
Clinique de la Sauvegarde /ID# 229087
Lyon, 69009
Cabinet de rhumatologie /ID# 229091
Mennecy, Essonne, 91540
CHU Montpellier - Hôpital Saint Eloi /ID# 228829
Montpellier, Herault, 34295
CHU Montpellier - Hôpital Saint Eloi /ID# 240980
Montpellier, Herault, 34295
CHU Nice -Hopital Pasteur /ID# 229088
Nice, Provence-Alpes-Côte d'Azur Region, 06002
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 234258
Orléans, 45067
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 244006
Paris, Paris, 75679
AP-HP - Hopital Saint-Antoine /ID# 228795
Paris, 75012
Hopital Pitie Salpetriere /ID# 243309
Paris, 75013
Centre de Soins Osteoarticulaires Ambulatoires /ID# 244737
Paris, 75015
AP-HP - Hopital Bichat - Claude-Bernard /ID# 228837
Paris, 75018
GH Diaconesses Croix Saint-Simon /ID# 238548
Paris, 75020
HCL - Hopital Lyon Sud /ID# 228819
Pierre-Bénite, Rhone, 69495
Polyclinique Courlancy /ID# 229093
Reims, Marne, 51100
CHU de Rennes - Hospital Sud /ID# 228842
Rennes, 35203
Hôpital Charles-Nicolle /ID# 229096
Rouen, 76000
CHU de SAINT ETIENNE - Hopital Nord /ID# 228836
Saint Priest EN Jarez, Pays de la Loire Region, 42270
CH Saint Nazaire /ID# 233186
Saint-Nazaire, 44600
CHU Toulouse - Hopital Purpan /ID# 228818
Toulouse, Haute-Garonne, 31059
Spain23 sites
Hospital Universitario Torrecardenas /ID# 252804
Almería, 04009
Complejos Hospitalario Universitario de Badajoz /ID# 249036
Badajoz, 06010
Hospital Universitario Germans Trias i Pujol /ID# 249030
Badalona, Barcelona, 08916
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 249042
El Palmar, Murcia, 30120
Hospital Campus de la Salud /ID# 252805
Granada, 18016
Hospital Juan Ramon Jimenez /ID# 249040
Huelva, 21005
Hospital Universitario de Jaen /ID# 249041
Jaén, 23007
Hospital San Pedro /ID# 249028
Logroño, La Rioja, 26006
Hospital Universitario Lucus Augusti /ID# 255820
Lugo, 27003
Hospital Universitario Ramon y Cajal /ID# 249035
Madrid, 28034
Hospital Universitario 12 de Octubre /ID# 249033
Madrid, 28041
Hospital de Mérida /ID# 249037
Mérida, Badajoz, 06800
Hospital Río Carrión /ID# 249027
Palencia, 34005
Hospital Universitario Son Llàtzer /ID# 249032
Palma de Mallorca, Las Palmas, 07198
Hospital Universitario Canarias /ID# 249043
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Hospital Infanta Sofia /ID# 249034
San Sebastián de los Reyes, Madrid, 28702
Hospital Universitario Nuestra Señora de Candelaria /ID# 249044
Santa Cruz de Tenerife, 38010
Complejo Hospitalario Universitario de Santiago /ID# 249025
Santiago de Compostela, A Coruna, 15076
Hospital Universitario Virgen Macarena /ID# 249039
Seville, 41009
Hospital Universitario Virgen del Rocio /ID# 249038
Seville, 41013
Hospital Universitario Mutua Terrassa /ID# 249031
Terrassa, Barcelona, 08221
Hospital Clinico Universitario de Valladolid /ID# 252001
Valladolid, 47003
Hospital Virgen de la Concha /ID# 249026
Zamora, 49022
Russia19 sites
Chelyabinsk Regional Clinical Hospital /ID# 244741
Chelyabinsk, Chelyabinsk Oblast, 454087
Regional Clinical Hospital of Kaliningrad region /ID# 238475
Kaliningrad, Kaliningrad Oblast, 236016
Research Institute of Rheumatology named after V.A. Nasonova /ID# 238479
Moscow, Moscow, 115522
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 232510
Moscow, Moscow Oblast, 129110
City Clinical Hospital #52 /ID# 238477
Moscow, 123182
Orenburg State Medical University /ID# 233183
Orenburg, 460000
Republican hospital named after V.A. Baranov /ID# 231173
Petrozavodsk, 185019
Nort-Western State Medical University n.a. Mechnikov /ID# 231172
Saint Petersburg, Sankt-Peterburg, 193015
Clinical Rheumatologic Hospital No 25 /ID# 231171
Saint Petersburg, 190068
Military Medical Academy n.a. Kirov /ID# 242363
Saint Petersburg, 194044
Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 231169
Samara, Samara Oblast, 443095
Clinic of Samara State Medical University /ID# 241166
Samara, 443079
GBUZ RM Mordovia Republican Central Clinical Hospital /ID# 244738
Saransk, Mordoviya, Respublika, 430901
Budgetary Institution of the Khanty-Mansiysk Autonomous Okrug-Yugra Surgut Dist /ID# 242369
Surgut, 628400
LLC MC RevmaMed /ID# 238478
Syktyvkar, Komi, 167031
Nebbiolo Clinical Research Center /ID# 231167
Tomsk, 634009
ChUZ Clinical Hospital RZD-Medicine /ID# 233185
Ulan-Ude, Buryatiya, Respublika, 670002
Ulyanovsk Regional Clinical Hospital /ID# 238334
Ulyanovsk, 432017
Yaroslavl State Medicat University /ID# 231168
Yaroslavl, 150000
Canada15 sites
Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 246213
Dundas, Ontario, L9H 1B7
Arthur Karasik Medicine Professional Corporation /ID# 241932
Etobicoke, Ontario, M9C 5N2
Lau Bacchus Professional Medicine Corp /ID# 242591
Hamilton, Ontario, L8N 1Y2
Credit Valley Rheumatology /ID# 241948
Mississauga, Ontario, L5M 2V8
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 249765
Montreal, Quebec, H1T 2M4
Applied Medical Informatics Research Inc. (AMIR) /ID# 246284
Montreal, Quebec, H4A 3T2
The Waterside Clinic /ID# 248678
Orillia, Ontario, L3V 1T5
Groupe de Recherche en Maladies Osseuses Inc /ID# 241111
Sainte-Foy, Quebec, G1V 3M7
Dr Naik-Medical Professional Corporation-Alliance Health /ID# 246516
Saskatoon, Saskatchewan, S7H 5M7
CIUSSS de l'Estrie - CHUS /ID# 247572
Sherbrooke, Quebec, J1G 2E8
Dr. Juris Lazovskis Inc. /ID# 246574
Sydney, Nova Scotia, B1S 3N1
Artus Health Center /ID# 241966
Vancouver, British Columbia, V5Z 1J9
Dr. Sabeen Anwar Medicine Professional Corporation /ID# 241933
Windsor, Ontario, N8X 1T3
Manitoba Clinic /ID# 246217
Winnipeg, Manitoba, R3A 1M3
CIADS Research Co Ltd /ID# 247520
Winnipeg, Manitoba, R3N 0K6
Greece14 sites
Vougiouklakeio S.A. /ID# 246476
Aigáleo, 12242
General Hospital of Athens Ippokratio /ID# 241133
Athens, Attica, 11527
General Hospital of Athens Laiko /ID# 241128
Athens, Attica, 11527
Naval Hospital of Athens /ID# 241129
Athens, 11521
KAT Atttica General Hospital /ID# 243063
Athens, 14561
424 General MILITARY Hospital /ID# 241127
Efkarpia (Thessalonikis), Thessaloniki, 56429
University General Hospital of Heraklion PA.G.N.I /ID# 241124
Heraklion, Crete, 71500
Duplicate_General Hospital of Thessaloniki Agios Pavlos /ID# 243823
Kalamaria, 55134
Iaso /ID# 245137
Marousi, 15123
Olympion General Clinic SA /ID# 251794
Pátrai, 26443
University General Hospital of Patras /ID# 243795
RION Patras Achaia, 26504
Euromedica Blue Cross Gen Clin /ID# 244945
Thessaloniki, 54636
General Hospital of Thessaloniki Hippokrateio /ID# 243796
Thessaloniki, 54642
Euromedica General Clinic /ID# 241126
Thessaloniki, 54645
Belgium10 sites
Onze Lieve Vrouw Hospital /ID# 238963
Aalst, 9300
Université Libre de Bruxelles - Hôpital Erasme /ID# 238961
Anderlecht, Brussels Capital, 1070
AZ Sint-Jan Brugge /ID# 238964
Bruges, 8000
CHU Brugmann /ID# 238962
Brussels, 1020
Rhumaconsult SPRL /ID# 231439
Charleroi, Hainaut, 6000
Reumacentrum /ID# 231437
Genk, 3600
ReumaClinic /ID# 231438
Genk, 3600
CHU de Liège /ID# 231440
Liège, Liege, 4000
AZ Damiaan /ID# 231441
Ostend, 8400
AZ-Delta /ID# 238966
Roeselare, West-Vlaanderen, 8800
Australia8 sites
Genesis Research Services /ID# 231593
Broadmeadow, New South Wales, 2292
Campbelltown Hospital /ID# 231462
Campbelltown, New South Wales, 2560
Royal Prince Alfred Hospital /ID# 232417
Camperdown, New South Wales, 2050
Barwon Rheumatology Services /ID# 230068
Geelong, Victoria, 3220
Peninsula Rheumatology /ID# 240172
Langwarrin, Victoria, 3910
Joint West Rheumatology /ID# 231461
Murdoch, Western Australia, 6150
BJC Health /ID# 230066
Parramatta, New South Wales, 2150
Paratus Clinical Research Woden /ID# 231460
Phillip, Australian Capital Territory, 2606
Israel8 sites
Hillel Yaffe Medical Center /ID# 241869
Hadera, H_efa, 38100
Bnai Zion Medical Center /ID# 241866
Haifa, H_efa, 3339419
The Lady Davis Carmel Medical Center /ID# 241867
Haifa, H_efa, 34362
Meir Medical Center /ID# 241868
Kfar Saba, Central District, 4428164
Galilee Medical Center /ID# 241870
Nahariya, Northern District, 2210001
The Chaim Sheba Medical Center /ID# 241305
Ramat Gan, Tel Aviv, 5265601
Tel Aviv Sourasky Medical Center /ID# 241864
Tel Aviv, Tel Aviv, 6423906
The Baruch Padeh Medical Center Poriya /ID# 249797
Tiberias, Northern District, 15208
Argentina5 sites
Hospital Italiano La Plata /ID# 230779
La Plata, Buenos Aires, 1902
CER Instituto Medico /ID# 230782
Quilmes, Buenos Aires, 1878
Clinica Regional del Sud /ID# 248866
Río Cuarto, 5800
Instituto CAICI S.R.L /ID# 230781
Rosario, Santa Fe Province, 2000
Duplicate_CIMER /ID# 230780
San Miguel de Tucumán, Tucumán Province, 4000
Bulgaria5 sites
Prof. Anastas Batalov AIPSMP-VBR EOOD /ID# 249788
Plovdiv, 4000
Medical center Unimed /ID# 249618
Plovdiv, 4023
"Ambulatory for individual practice of specialized medical help for internal dis /ID# 249791
Sofia, 1000
ASIMP Rheumatology Centre "St. Irina" EOOD /ID# 249789
Sofia, 1750
AIPSMPR -d-r Gerganov /ID# 249749
Varna, 9002
Hungary5 sites
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 239939
Budapest, 1134
Debreceni Egyetem Klinikai Kozpont /ID# 239936
Debrecen, Hajdú-Bihar, 4032
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 239937
Debrecen, 4031
Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 239940
Hévíz, 8380
Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 239938
Kecskemét, 6000
Kuwait5 sites
Adan Hospital /ID# 229679
ADAN
Jahra Hospital /ID# 229671
Al Jahra, 52700
Mubarak Hospital /ID# 250478
Hawalli, 46300
Mubarak Hospital /ID# 251777
Hawalli, 46300
Farwaniya Hospital /ID# 231445
Kuwait City, 85000
Poland4 sites
Ma?opolskie Badania Kliniczne Sp. z o.o. /ID# 255509
Cracow, 30-040
Jerzy ?wierkot Indywidualna Specjalistyczna Praktyka Lekarska /ID# 244289
Oława, 55-200
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 243225
Poznan, Greater Poland Voivodeship, 61-545
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji /ID# 243232
Warsaw, Masovian Voivodeship, 02-637
Switzerland3 sites
Studio Zanisi /ID# 255681
Locarno, Canton Ticino, 6600
Kantonsspital St. Gallen /ID# 230696
Sankt Gallen, Canton of St. Gallen, 9007
Rheumatologisches Versorgungszentrum Weinfelden /ID# 239435
Weinfelden, Thurgau, 8570
Mexico2 sites
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 238815
Guadalajara, Jalisco, 44650
Private Office Dr. Orozco /ID# 255210
Guadalajara, Jalisco, 44650
United Arab Emirates2 sites
Cleveland Clinic Abu Dhabi /ID# 256292
Abu Dhabi
AlAin Hospital /ID# 233803
Dubai
About this study
Official title: Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Axial Spondylarthritis (UPSTAND)
Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in axSpA participants.
Upadacitinib is being developed for the treatment of axSpA. Approximately 650 adult participants with active-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific.
Read more
Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. Participants will be followed for 12 months.
There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.
- Conditions
- Axial Spondylarthritis (axSpA)
- Keywords
- Axial Spondylarthritis (axSpA), Upadacitinib, RINVOQ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving Upadacitinib | Participants receiving Upadacitinib for axial spondyloarthritis (axSpA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with a Total Spinal Pain Score < 4 and >= 2 Unit (0 - 10) Improvement
Total spinal pain consists of the mean of two 0-10 numerical rating scale (NRS) questions: total back pain during the previous week and nocturnal back pain during the previous week.
Measured: Baseline (Week 0) to Week 12
Percentage of Participants Maintaining Total Spinal Pain < 4 Among Participants Who Achieved Total Spinal Pain < 4 and >= 2 unit (0 - 10) Improvement from Baseline at Week 12
Total spinal pain score consists of the mean of two 0-10 NRS questions: total back pain during the previous week and nocturnal back pain during the previous week.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start30 Apr 2021
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial Spondylarthritis (axSpA)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846244
- Sponsor's protocol ID
- P20-410
- Acronym
- UPSTAND
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2021
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Axial Spondylarthritis (UPSTAND)
- ClinicalTrials.gov ID
- NCT04846244
- Acronym / sponsor ID
- UPSTAND / P20-410
- Conditions
- Axial Spondylarthritis (axSpA)
- Keywords
- Axial Spondylarthritis (axSpA), Upadacitinib, RINVOQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in axSpA participants.
Upadacitinib is being developed for the treatment of axSpA. Approximately 650 adult participants with active-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific.
Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. Participants will be followed for 12 months.
There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Upadacitinib | – | –Participants receiving Upadacitinib for axial spondyloarthritis (axSpA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with Radiographic Axial Spondylarthritis (r-axSpA) who have been prescribed upadacitinib in the course of routine practice according to relevant approved licenses.
Key inclusion criteria (5 listed)
- Clinical diagnosis of Axial Spondylarthritis (axSpA) according to the ASAS criteria.
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 at Baseline.
- Total back pain score >= 4 at Baseline.
- Inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to contraindication for NSAIDs as defined by the investigator.
- Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.
Key exclusion criteria (6 listed)
- Prior exposure to any Janus kinase (JAK) inhibitor.
- Participants demonstrating active symptoms of fibromyalgia as per clinical diagnosis.
- Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
- Unwillingness or inability to comply with the study requirements, including completion of patient reported outcome questionnaires.
- Participants who cannot be treated with upadacitinib according to the applicable approved label (e.g., contraindications).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants with a Total Spinal Pain Score < 4 and >= 2 Unit (0 - 10) Improvement
Time frame: Baseline (Week 0) to Week 12
Total spinal pain consists of the mean of two 0-10 numerical rating scale (NRS) questions: total back pain during the previous week and nocturnal back pain during the previous week.
Percentage of Participants Maintaining Total Spinal Pain < 4 Among Participants Who Achieved Total Spinal Pain < 4 and >= 2 unit (0 - 10) Improvement from Baseline at Week 12
Time frame: Week 52
Total spinal pain score consists of the mean of two 0-10 NRS questions: total back pain during the previous week and nocturnal back pain during the previous week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Axial Spondylarthritis (axSpA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
160 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondylarthritis (axSpA), run by AbbVie at 160 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 160 sites in France, Spain, Russia, Canada, Greece and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with a Total Spinal Pain Score < 4 and >= 2 Unit (0 - 10) Improvement (time frame: Baseline (Week 0) to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.